Duque De Caxias

Researchers are evaluating if benzathine penicillin can prevent maternal syphilis in pregnant women at higher risk and assess its safety. This randomized, unblinded Phase 2 clinical trial compares benzathine penicillin prophylaxis plus counseling and intensified screening to routine care with counseling and testing alone. The study focuses on reducing syphilis rates during pregnancy and preventing congenital syphilis in the newborn. Participants will be assigned to one of two groups one receives counseling on STI prevention, monthly treponemal and non-treponemal tests starting at 28 weeks of pregnancy, and intramuscular injections of 2.4 million units of benzathine penicillin if tests are negative at 28, 32, and 36 weeks the other group receives counseling and the same testing schedule without the penicillin injections. If any participant tests positive during the study, they will be treated according to Brazilian Ministry of Health guidelines. During the study, pregnant participants will visit the clinic monthly for injections and tests from 28 weeks until delivery, which lasts about 4 to 5 months. Researchers will monitor for maternal syphilis infection at delivery, infant health in the first 4 weeks of life, and any adverse events including injection site reactions and pregnancy complications. The study also tracks participant adherence and safety outcomes throughout pregnancy and shortly after delivery.